Our Medical Device Auditing Solutions act as your independent quality assurance, ensuring compliance and mitigating risks. We streamline the auditing process, enabling you to focus on healthcare innovation with confidence.
Working with you across all your auditing needs.
Helping simplify and well-organise the workflow and collaboration process of compiling audits.
SUPPLY CHAIN AUDITS
Working with your supply chain per the Supplier Quality Agreement, ensuring compliance with relevant regulatory requirements, regulations and standards.
We can help you get ready for inspection. We offer a proactive process of 'getting ready' for an inspection by a regulatory authority (such as FDA).
Performed by a qualified Lead Auditor, from within your organisation who is independent of the activities being audited.
Effective Audit facilitation is a crucial part of any audit process. We conduct goal-oriented communications, mediation and negotiation with and between the process partners who are to be audited.
Supporting your stakeholders to effectively address and resolve observations and findings raised.